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The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study (ImPrOVE)

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ClinicalTrials.gov Identifier: NCT01102140
Recruitment Status : Terminated (Investigator left University of Michigan)
First Posted : April 13, 2010
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Jennifer Cowger , MD, MS, University of Michigan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Cardiomyopathy
Heart Failure
Interventions: Drug: POMx, pomegranate polyphenol extract
Drug: Sugar Pill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
POMx

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

Control- Sugar Pill

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill


Participant Flow:   Overall Study
    POMx   Control- Sugar Pill
STARTED   13   7 
COMPLETED   10   5 
NOT COMPLETED   3   2 
Lost to Follow-up                1                0 
Investigator terminated study                2                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
POMx

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

Control- Sugar Pill

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Total Total of all reporting groups

Baseline Measures
   POMx   Control- Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   7   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  76.9%      5  71.4%      15  75.0% 
>=65 years      3  23.1%      2  28.6%      5  25.0% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57 
 (49 to 64) 
 58 
 (52 to 64) 
 57 
 (50 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      2  28.6%      2  10.0% 
Male      13 100.0%      5  71.4%      18  90.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   7.7%      0   0.0%      1   5.0% 
White      12  92.3%      6  85.7%      18  90.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1  14.3%      1   5.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   7   20 


  Outcome Measures

1.  Primary:   Thiobarbituric Reactive Substances (TBARS)   [ Time Frame: baseline and after 12 weeks ]

2.  Secondary:   F-8 Isoprostanes   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Procollagen Types I (PINP) and III (PIIINP)   [ Time Frame: baseline and 12 weeks ]

4.  Secondary:   Asymmetric Dimethylarginine (ADMA)   [ Time Frame: baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jennifer Cowger
Organization: University of Michigan
phone: 7345464911
e-mail: jennifercowger@gmail.com



Responsible Party: Jennifer Cowger , MD, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT01102140     History of Changes
Other Study ID Numbers: IMPROVEHF
First Submitted: April 12, 2010
First Posted: April 13, 2010
Results First Submitted: May 18, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017